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FDA Halts New Applications From Indian Drug Maker's Plant
Date:2/25/2009

pliance at the Center for Drug Evaluation and Research, said during the teleconference. In addition, the company falsified data about production practices, she said.

The agency will begin reviewing applications only after Ranbaxy is able to prove to the agency that all of its data are correct and the FDA no longer has a concern about the data in the applications, Autor said.

While most products made by the company in the United States are not part of the FDA action, Autor added, there are some U.S. products that are affected.

Two of them are cholesterol-lowering drugs, pravastatin (Pravachol) and imvastatin (simvastatin), and an antihistamine known as pheniramine (Avil), Autor said.

The FDA is asking Ranbaxy for assurance that none of the data on these drug applications are from the Paonta Sahib facility, she explained.

Throckmorton was careful to say that the FDA has received no reports of harm caused by Ranbaxy products made in the United States or in the Paonta Sahib plant.

In addition, the agency is advising patients not to stop taking any medications without talking with their doctors first, he said.

More information

For more information on drug safety, visit the U.S. Food and Drug Administration .



SOURCES: Feb. 25, 2009, teleconference with: Douglas Throckmorton, M.D., deputy director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, and Deborah Autor, J.D., director, Office of Compliance, Center for Drug Evaluation and Research, FDA


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